Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer
Faeth Therapeutics announced that the FDA has granted Fast Track designation to the combination of PIKTOR (sapanisertib and serabelisib) with paclitaxel for treating patients with advanced or recurrent endometrial cancer who have tumors with a PI3K/AKT/mTOR pathway alteration. The designation applies to the company's lead program PIKTOR.
Why it matters — Fast Track designation may expedite development and review of PIKTOR, a lead program central to Faeth's oncology pipeline, in a biomarker-selected advanced endometrial cancer setting.